the smart solution for New Brunswick jobs

Head of External Engagement

Company: Pharmaceuticals, New Brunswick, NJ
Location: New Brunswick
Posted on: December 9, 2018

Job Description:

Job Purpose To define and implement an external engagement strategy, governance and associated capabilities to ensure that Company is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science and technology, quality and compliance. Leading a network of company KOLs across GPS that can monitor and influence the evolving external environment and execute internal change where needed based on external signals to continuously improve our products, systems and submissions in service of our patients and company goals and priorities, is a key outcome of the role. Ensure that internal processes and strategies are in place to support external representation. Design and implement internal processes and communication mechanisms to assess emerging regulatory expectations for their impact on the company, and to achieve the overall vision and objectives described above. Ensure that benchmarking information which is obtained through external engagement is effectively shared within the company and used to continuously improve products, development and manufacturing processes, regulatory submissions and overall quality system. Actively engage with regulators and industry peers in industry associations, working groups, activities and topics supporting the implementation of the external engagement strategy and vision for Company. Major Activities of the role

1. Assess the landscape of major industry associations and joint regulator/industry initiatives to decide where the company must be represented and why, including major impact expected. Ensure that representation covers the executive level for policy setting and strategy as well as the technical subject matter expert level.

2. Design and implement governance processes and cross-divisional/cross-functional governance bodies that support the nomination and participation of internal key opinion leaders in Industry Associations and joint Regulator/Industry initiatives.

3. Ensure that a network of subject matter experts exists and supports the internal key opinion leaders in their external engagement activities.

4. Engage with regulators and industry associations to represent the company on strategic topics.

5. Ensure early identification and assessment of emerging topics/expectations to define the company´s strategy and involvement.

6. Ensure effective communication of the outcome of external engagement across the organization, and ensure that there is a close loop mechanism to drive company action and impact where needed to incorporate changes to products and processes, regulatory submissions and quality systems. Ensures that external engagement activities are shared throughout the company, including the company quality council and other business forums across R&D and Global Product Development and Supply (GPS).

7. Ensure timely and effective cross-functional review and commenting on emerging and new regulations/guidelines.

8. Ensure that there is a process in place to assess emerging and new regulations on their impact to the company and support the organization in timely and effective implementation of new requirements. Ensure that a feedback loop is in place and effectively working to integrate such new requirements into the company´s products, submissions and overall development and manufacturing processes and quality system. Report on the progress of these activities and their impact to executive leadership in R&D and GPS.

Ensure that external engagement is used to effectively benchmark best practices in the industry to continuously improve products, submissions, and internal development and manufacturing processes and systems.

Desired Expertise of the Candidate Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline. Languages: Fluent in English (oral and written); additional languages desirable Minimum of 20 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Quality, Manufacturing and/or Product Development/Regulatory. Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, WHO). Actively engaged in major industry associations (e.g. EFPIA, PhRMA, PDA, ISPE, DIA) and joint regulator/industry initiatives (e.g. ICH). Highly regarded within regulatory/industry peer groups and recognized as a key opinion leader by major regulatory bodies as a thought leader on Quality and/or Regulatory topics. Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients. High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in teams. Key Factors to measure success of the role An external engagement strategy is defined and implemented (aligned with Company business imperatives) to ensure that the company is represented across the GxP areas of the product lifestyle in major Industry Associations/Regulatory forums at both the strategy/policy setting level as well as for technical topics, to achieve the overall vision that Company is recognized as a thought leader in the external environment. Internal processes and systems to support external representation are implemented and effectively working. Benchmarking results and emerging expectations from external activities are communicated effectively across internal divisions/functions and used to drive action and continuously improve internal products, submissions and quality and scientific processes and systems. Through the incumbent’s engagement with regulators and industry peers, the reputation of the company is continuously enhanced. The company is involved in strategic initiative with regulators and considered a “go to” organization for benchmarking by peer companies and regulators. An internal robust pipeline of talent and external engagement succession planning process is in place to ensure continuous representation in major Industry Associations/Regulatory forums on the strategy and policy setting level as well as for technical topics. Strategic Importance and Impact of the Global External Engagement Role for Company Achieve the vision to be recognized by Regulatory Authorities as a thought leader in the Industry in the areas of innovation, science and technology, quality and regulatory compliance, and continuous improvement. Strategic role to prepare the internal organization for emerging regulatory expectations in GxP areas, across the lifecycle of biopharmaceutical products at Company. High visibility of the incumbent representing the company in major industry initiatives and in interactions with regulators, as well as internal visibility with executive leadership, up to and including Company executive leadership team members.

Keywords: Pharmaceuticals, New Brunswick, NJ, New Brunswick , Head of External Engagement, Executive , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Account Manager
Description: Overview At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking (more...)
Company: New York Blood Center
Location: New Brunswick
Posted on: 12/11/2018

Physician: Hospitalist Medical Director in Highly Desired We
Description: Premier multi-specialty group in Westchester, NY seeks a Medical Director of the Hospitalist team. This established, 9 physician hospitalist team is responsible for rounding and admissions of the MSG's (more...)
Company: CompHealth
Location: White Plains
Posted on: 12/11/2018

VP - Principal, Technology Product Manager (Electronic Forms)
Description: Leads product management, strategy and development for our new dynamic, electronic Forms Management product on Pershing's Wealth Management platform. Uses broad understanding of standard and custom forms (more...)
Company: The Bank of New York Mellon
Location: Jersey City
Posted on: 12/11/2018

Nurse - Medical Case Manager - Seasonal
Description: Excellence In Everything We Touch Position Summary This is a work from home position requiring local field case management travel. To provide effective case management services in an appropriate, cost (more...)
Company: Broadspire
Location: Philadelphia
Posted on: 12/11/2018

Project Manager/Senior Consultant
Description: Job Requirements nbsp nbsp Requirements: nbsp - Great educational background, preferably in the fields of computer science
Company: Robert Half Technology
Location: Philadelphia
Posted on: 12/11/2018

Director, Default Call Center
Description: This position is responsible for the overall strategy and performance of the Cenlar s default call center operations including collections, SPOCs, and Loss mitigation outreach efforts in accordance with (more...)
Company: Cenlar FSB
Location: Trenton
Posted on: 12/11/2018

Construction Project Manager - Home Reconstruction
Description: Home Reconstruction Project Manager Residential Capital Management Resicap is the leading vertically integrated solution for institutional owners of single-family residential assets in the United States. (more...)
Company: Ameritrust Residential Services
Location: Trenton
Posted on: 12/11/2018

ServiceNow Lead Software Engineer, Vice President
Description: Discover your opportunity with Mitsubishi UFJ Financial Group MUFG , the 5th largest financial group in the world with total assets of over 2.4 trillion as ranked by SNL Financial, April 2016 and (more...)
Company: MUFG
Location: Jersey City
Posted on: 12/11/2018

Construction Project Manager - Home Reconstruction
Description: Residential Capital Management Resicap is the leading vertically integrated solution for institutional owners of single-family residential assets in the United States. Our services include asset acquisition/valuation, (more...)
Company: Ameritrust Residential Services
Location: Scranton
Posted on: 12/11/2018

Nurse Manager of Operating Room RN
Description: Job Summary: br br As a talented and dedicated Operating Room OR Nurse RN Manager, your career is very valuable to people and with your special Operating Room skill set, you can make a difference. (more...)
Company: Chapel Hill Solutions
Location: Newark
Posted on: 12/11/2018

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds